Kornimate/medical-research-clean huggingface dataset:
relapse-prevention study with lu aa21004 (vortioxetine) in patients with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the study will evaluate the long-term maintenance of efficacy of lu aa21004 in patients with generalized anxiety disorder (gad) who responded to acute treatment with lu aa21004.

gad is a common and disabling mental disorder associated with substantial medical and psychiatric comorbidity and occupational impairment. it is characterized by inappropriate or excessive anxiety and worrying that persists over time for more than six months. common features include apprehension, with worries about future misfortune; inner tension and difficulty in concentrating; motor tension, with restlessness, tremor and headache; and autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort. gad is typically a chronic disorder with a high relapse rate and therefore requires effective long-term treatment. long-term studies are necessary to demonstrate that the short-term effect is maintained.

Eligibility criteria:
inclusion criteria: the patient has gad as the primary diagnosis according to dsm-iv-tr criteria (classification code 300.02). * the patient has a ham-a total score \>=20 at screening and baseline visits * the patient has a ham-a score \>=2 on both item 1 (anxious mood) and item 2 (tension) at screening and baseline visits * the patient has a madrs total score \<=16 at screening and baseline visits exclusion criteria: * any current psychiatric disorder other than gad as defined in the dsm-iv-tr (assessed with the mini) * any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the dsm-iv-tr * women of childbearing potential not using effective contraception other protocol-defined inclusion and exclusion criteria may apply.

Keywords: relapse prevention gad maintenance double-blind multicentre
a study to assess the safety and tolerability of rc88 for patients with advanced solid tumours

Conditions: Advanced Solid Tumours

Summary: the purpose of this study is to allow rc88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

the main purpose of this phase i study is to test rc88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

Eligibility criteria:
inclusion criteria: 1. all subjects must be ≥ 18 years at the first screening examination / visit. 2. eastern cooperative oncology group (ecog) performance status of 0 to 1. 3. life expectancy of at least 12 weeks 4. phase i must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,patients with partial,advanced or metastatic malignant solid tumors; 5. phase ii-advanced malignant solid tumor with msln expression 6. patients with malignant pleural mesothelioma were assessed using mrecist criteria, and those with other cancers were assessed using recist v1.1 criteria 7. phase ii-mesothelin (msln) positive as confirmed by the central laboratory. 8. adequate organ function 9. voluntarily sign an informed consent form exclusion criteria: 1. cancer metastases in the brain 2. active infection or past hepatitis b or c infection 3. major surgery less than 1 month before the start of the study 4. uncontrolled heart disease 5. history of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
does a nasal instillation of vardenafil normalize the nasal potential difference in cystic fibrosis patients?

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to investigate the effect of a nasal instillation of vardenafil on nasal potential difference in cystic fibrosis patients homozygous for the f508del mutation

cftr protein has been shown to be an ohmic, small conductance channel regulated by camp intracellular levels that are balanced by degradation through cyclic nucleotide phosphodiesterases (pde). several families of pdes with varying selectivities for camp and/or cgmp have been identified.pde5 is highly specific for cgmp and is involved in the regulation of the intracellular concentration of cgmp in various tissues. recently, it has been shown, in a preclinical model of transgenic mice, that pharmacological doses of sildenafil and vardenafil, two clinically approved pde5 inhibitors, stimulate chloride transport activity of the mutant f508del-protein (lubamba et al, 2008); this parameter has been assessed by means of the nasal potential difference (npd). an increasing effect of sildenafil on the expression of f508del-cftr protein (dormer et al,2005) was originally reported in nasal epithelial cells harvested from patients with cystic fibrosis and cultured on impermeable supports, a configuration that allows interaction of drugs with the apical side of epithelia. this study aims at investigating the effect of a single local administration of vardenafil on npd measurements in cf patients homozygous for the f508del mutation.

Eligibility criteria:
inclusion criteria: * cystic fibrosis patients homozygous for the f508del mutation as confirmed by a genetic test * aged 14 years and older * male and female * fev1 \>50% of predicted normal exclusion criteria: * acute respiratory tract infection or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of visit 1 * any condition prohibiting the correct measurement of the npd * active or passive smoking * planned treatment or treatment with another investigational drug or therapy within 1 month prior to randomisation

Keywords: cystic fibrosis vardenafil nasal instillation nasal potential difference
comparing recipient site preparation using dermabrasion, dermaroller and liquid nitrogen induced blister in non cultured epidermal cell suspension in stable vitiligo

Conditions: Vitiligo

Summary: a comparative study between recepient site preparation using dermabrasion, liquid nitrogen induced blister and dermarolling system in autologous non cultured epidermal cell suspension procedure in stable vitiligo patients

with a sample size of 36, 3 patches of a single stable vitiligo patient will be prepared using dermabrasion,dermaroller system and liquid nitrogen induced blister. the autologous non cultured epidermal cell suspension will be prepared using cold trypsinization from the skin graft taken from patient.after preparation of the recipient site,the suspension is applied and dressing is done.the patient is followed up for 3 months and extent of repigmentation,colour match,pattern of repigmentation,patient satisfaction score, vitiligo quality of life index before and after surgery and effect on acral vs non acral regions are studied for all the 3 methods.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of generalized vitiligo * patients with symmetrical lesions of size \> 1.5cm x 1cm present on trunk or extremities including acral areas. * vitiligo lesions has been stable for 1 year. * disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo . * maximum size of vitiligo patches to be selected for surgery will not be \>100cm2. exclusion criteria: * age less than 18 years * pregnancy and lactation * patient with actively spreading vitiligo * history of koebnerisation * history of hypertrophic scars or keloidal tendency * bleeding disorders * patients with unrealistic expectation
maraviroc in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (mtx) is safe and effective in the treatment of rheumatoid arthritis in adult patients.

following a planned interim analysis in the poc component on 21 august 2008 by the internal dmc (data monitoring committee) of study a4001056, the trial was discontinued due to lack of efficacy. all participating investigators/country offices and monitors were notified on 22 august 2008 to cease patient enrollment. the dmc indicated that maraviroc was well tolerated in the rheumatoid arthritis patients and there were no safety concerns in the study. the termination date of this trial was 07 october 2008 when the last patient last visit occurred.

Eligibility criteria:
inclusion criteria: * must be legal age of consent * must have active rheumatoid arthritis based upon the american college of rheumatology (acr) 1987 (revised criteria); minimum disease criteria required for entry into the efficacy component of the study * must meet acr 1991 revised criteria for global functional status in ra, class i, ii, or iii * must be receiving methotrexate for at least 12 weeks duration and on a stable dose for 4 weeks. exclusion criteria: * diagnosed with any other inflammatory arthritis or a secondary non-inflammatory arthritis that would interfere with disease activity assessments. * subject receiving prior treatment with certain medications for rheumatoid arthritis * tuberculosis and/or a positive tuberculin reaction * significant trauma or major surgery within 2 months * history of alcohol and/or drug abuse outside of a defined period of abstinence * history of or a finding at screening of postural hypotension * any condition that would affect the oral absorption of the drug * history of cancer and in remission less than 3 years or grade iii-iv congestive heart failure * having an infection of human immunodeficiency virus (hiv), hepatitis b or c or evidence of any active infection * abnormalities of clinical or laboratory assessments completed at the screening visit such as elevated liver enzymes, decreased hemoglobin or an abnormal ecg * having a positive chemokine receptor 5 (ccr5) delta 32 mutation * requiring the use of certain medications * lactating or pregnant women or subjects have reproductive potential unwilling to use an adequate method of birth control * chronic or recent serious or life-threatening infection; severe , progressive and/or uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease within 12 weeks of the first dose.
prospective study of arthrodesis of finger distal interphalangeal joints using the kerifuse device

Conditions: Osteoarthritis Finger; Osteoarthritis Thumb

Summary: arthrodesis of a distal interphalangeal joint of the finger (dip) is mainly performed for a degenerated and painful joint. various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples. although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy. the aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the kerifuse shape memory implant.

arthrodesis of a distal interphalangeal joint of the finger (dip) is mainly performed for a degenerated and painful joint. various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples. although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy. the aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the kerifuse shape memory implant. main objective is to evaluate the bone fusion time in arthrodesis performed with the kerifuse shape memory implant. secondary objectives are : * to evaluate the fusion rate and its associated healing time * to evaluate patient satisfaction, including aesthetic aspect * to assess overall hand function * to evaluate the radiological evolution of the kerifuse® implant and its implantation site * to evaluate the radiological evolution of the arthrodesis angle between the post-operative situation and the final fusion position

Eligibility criteria:
inclusion criteria: * eligible patients with osteoarthritis of finger for an interphalangeal arthrodesis with kerifuse implant exclusion criteria: * pregnant or breastfeeding patient * patient with an intellectual disability and who therefore cannot follow the surgeon's instructions * patients with contraindications to surgery * patients with acute or chronic, local or systemic infections * patients with sensitivities or allergies to device components (nickel, titanium)
perfusion ct as a predictor for response to antiangiogenic therapy in patients with metastasized renal cell carcinoma

Conditions: Metastatic Renal Cancer

Summary: the purpose of this study is the evaluation of dynamic contrast-enhanced ct (perfusion-ct) for therapeutic response predicition in patients with metastasized renal carcinoma (mrcc) undergoing antiangiogenetic therapy (aat) with multikinase inhibitors. in this study patients with mrcc under aat will be examined with 3 serial perfusion - ct scans - partially intergrated in their regular staging ct scheme - at baseline (before aat start), 1 week after aat as well as 8 weeks after aat initialization. thereby selected intrabdomial or intrathoracic metastases will be monitored longitudinally with perfusion ct. pretreament and post-treament perfusion characteristics of the assessed metastatic lesions will be quantified and correlated with patient outcome.


Eligibility criteria:
inclusion criteria: * patients with metastasized renal cell carcinoma treated at the department of urology (university of munich - grosshadern campus) 1. with either - sunitinib (sutent®), pazopanib (votrient ®) bzw. sorafenib (nexavar®) as first-line therapy 2. with sunitinib (sutent®), pazopanib (votrient ®) bzw. sorafenib (nexavar®) as second-line therapy after failed first-line therapy, who are off therapy for at least 2 weeks * no contraindications against contrast-enhanced ct * obtained informed consent to participate in the study exclusion criteria: patients who have: * not given informed consent * known iodine allergy * high grade renal insuffiency (egfr \< 30ml/min) not on dialysis * overt hyperthyreoidism * singular metastases \<1cm in diameter * an increase of their baseline creatine levels of \>20% between ct examinations

Keywords: perfusion-ct mrcc antiangiogenic therapy response assessment
study to evaluate safety, efficacy, pharmacokinetics and pharmacodynamics of avelumab in combination with either crizotinib or pf-06463922 in patients with nsclc. (javelin lung 101)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or pf-06463922.

this is a phase 1b/2, open label, multi center, multiple dose, safety, pharmacokinetic and pharmacodynamic study of group a and group b in cohorts of adult patients with locally advanced or metastatic nsclc.

Eligibility criteria:
* inclusion criteria * diagnosis of advanced or metastatic nsclc. group a must be alk negative nsclc and group b must be alk positive nsclc * group a at least one prior regimen of therapy * group b any number of prior regimens. * mandatory tumor tissue available * at least one measurable lesion * ecog performance status 0 or 1 * adequate bone marrow, renal, liver and pancreatic function * negative pregnancy test for females of childbearing potential * group b phase 2: no prior systemic treatment for advanced or metastatic disease (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months prior to study entry. no prior tyrosine kinase inhibitor therapy is allowed at any time prior to study entry) exclusion criteria: * no prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody. * no severe or chronic medical conditions including gastrointestinal abnormalities or significant cardiac history * no active infection requiring systemic therapy * prior organ transplantation including allogenic stem cell transplantation.

Keywords: non-small cell lung cancer nsclc alk avelumab crizotinib pf-06463922
correlation between cytokines and the severity of meningococcal disease

Conditions: Meningococcemia

Summary: objectives: meningococcal disease (md) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. during meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. the aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during md, as well as relate the level of these cytokines to severity of md. design: prospective, nonrandomized study. setting: tertiary referral intensive care unit. patients: children and adults admitted with a clinical diagnosis of md. interventions: blood and cerebrospinal fluid will sample from children and adults with md.

meningococcal disease (md) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. during meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. the aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during md: il -4; il-6; il-10 and interferon alfa, as well as relate the level of these cytokines to severity of md, evaluated by occurrence of shock, acute renal failure, disseminated intravascular coagulation and survival. design: prospective, nonrandomized study. setting: tertiary referral intensive care unit. patients: children and adults admitted with a clinical diagnosis of md. interventions: blood and cerebrospinal fluid will sample from children and adults with md. measurements and main results: in process conclusions: in process

Eligibility criteria:
inclusion criteria: * clinical diagnostic of meningococcal disease exclusion criteria: * no meningococcal disease

Keywords: meningococcal disease cytokines
a prospective trial of povidone-iodine suppository before transrectal ultrasound guided prostate biopsy

Conditions: Infection; Prostatic Diseases; Misadventure During Aspirating Needle Biopsy

Summary: to assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

Eligibility criteria:
inclusion criteria: * who undergo transrectal prostate biopsy exclusion criteria: * patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy
evaluation of soluble st2 in patients receiving primary pci with st-elevation myocardial infarction

Conditions: Myocardial Infarction; Shock

Summary: st-elevation myocardial infarction (stemi) is an urgent symptom associated with sudden myocardial ischemia and st segment elevated in ecg. primary percutaneous coronary intervention (pci) re-open infarct artery efficiently for stemi patients. however, patients are readmitted shortly after the primary pci for several unfavorable clinical outcomes including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart failure. this study is intended to test the predictive ability of a new biomarker soluble st2 (sst2) in peripheral blood. previous studies have shown that elevated sst2 is highly associated with unfavorable clinical outcomes of patients with ischemia heart diseases and heart failure. this study will further investigate the ability of sst2 to predict unfavorable outcomes for stemi patients after primary pci.


Eligibility criteria:
inclusion criteria: * patients with first onset stemi receive primary pci according to 2013 accf/aha guideline for management of stemi exclusion criteria: * patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases or severe infection are excluded from this study.

Keywords: stemi primary pci sst2 prognosis
efficacy and safety of hydroxychloroquine for treatment of covid-19

Conditions: Pneumonia, Pneumocystis; Coronavirus; COVID-19

Summary: the study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of covid-19 pneumonia.

there is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of covid-19 pneumonia.

Eligibility criteria:
inclusion criteria: * the participants were diagnosed as covid-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by national health commission of the people's republic of china; * participants aged over 18; * written the informed consent. exclusion criteria: * hypersensitivity to chloroquine or hydroxychloroquine; * women during pregnancy; * severe heart, lung, kidney, brain, blood diseases or other important systemic diseases; * participants with retinal disease, hearing loss; * participants with severe neurological and mental illness; * subjects were considered to be unable to complete the study, or not suitable for the study by researchers. exit criteria: * subjects asked to withdraw the study * subject will benefit if withdraw according to researchers' suggestions

Keywords: pneumonia covid-19 hydroxychloroquine